Country Approval Associate

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Prepare, review, and coordinate Country Submissions in accordance with guidance and the global submission strategy.

• Assist in the preparation of submissions to the local Ministry of Health, as needed.

• Collaborate with internal departments on site start-up tasks and submission timelines.

• Ensure that submission processes are in line with the critical path for site activation.

• Meet company target cycle times for site activations.

• Reach out to investigators for activities related to submissions as required.

• Serve as a key country-level contact for Ethical or Regulatory submission activities.

• Work alongside start-up CRAs to create regulatory compliance review packages.

• Contribute to the development of country-specific Patient Information Sheets and Informed Consent Forms.

• Aid in negotiating grant budgets and payment schedules with sites.

• Input and maintain trial status information in tracking databases.

• Prepare and manage local country study files and filing processes.

• Stay informed about company and client SOPs, directives, and current regulatory guidelines.

⛳️ Requirements

• A Bachelor's degree or equivalent along with relevant formal academic or vocational qualifications.

• Previous experience ranging from 0 to 2 years that is comparable.

• Proficient oral and written communication skills.

• Outstanding interpersonal abilities.

• Keen attention to detail and documentation quality.

• Strong negotiation skills.

• Competent computer skills with the ability to learn necessary software.

• Proficient English language skills and grammar.

• Basic knowledge of medical/therapeutic areas and medical terminology.

• Ability to work both in a team setting and independently, as directed.

• Basic organizational and planning skills.

• Fundamental understanding of applicable regional/national regulatory guidelines and EC regulations.

• Consideration may be given to equivalency through a combination of relevant education, training, and/or directly related experience.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Experience working in a global team setting.

• Personal protective equipment provided and required for the work environment.